Implementation and Evaluation of a Post-Diagnostic Announcement Protocol at the CRMR RefeRet, Quinze-Vingts Hospital
NCT ID: NCT07292987
Last Updated: 2025-12-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
80 participants
INTERVENTIONAL
2025-12-31
2028-01-31
Brief Summary
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Eighty newly diagnosed adults will be randomly assigned to either usual care or an enhanced pathway that includes early follow-up with a nurse, structured emotional monitoring, and a psychologist visit at six months.
The study aims to determine if this structured support improves patient satisfaction and reduces anxiety and depression compared with standard care.
Detailed Description
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This prospective, monocentric, randomized study at the Quinze-Vingts National Ophthalmology Hospital tests a structured post-diagnostic support pathway that combines early nurse-led follow-up and systematic psychological support.
Eighty newly diagnosed patients aged 18-65 will be randomized into two parallel groups. The experimental group will receive early nurse consultations at 15 days and 6 months, psychological follow-up at 6 months, and repeated HADS assessments. The control group will receive usual care.
The primary outcome is patient satisfaction at 12 months (PREM). Secondary outcomes include changes in anxiety and depression (HADS) and feasibility feedback from nursing staff (RETEX).
Findings will inform the design of sustainable, multidisciplinary care models for rare eye diseases.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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Usual care group
Usual Care
Standard ophthalmologist consultation with optional psychologist consultation
Enhanced care group
Enhanced post-diagnostic support
Nurse-led and psychologist consultation
Interventions
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Enhanced post-diagnostic support
Nurse-led and psychologist consultation
Usual Care
Standard ophthalmologist consultation with optional psychologist consultation
Eligibility Criteria
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Inclusion Criteria
* Aged 18 to 65 years
* Male or female
* French-speaking
* Have a phone number
* Reside in France
Exclusion Criteria
* Participants enrolled in a therapeutic clinical trial within the past 12 months
* Individuals deprived of liberty by judicial or administrative decision
* Adults under legal protection or unable to provide informed consent
* Individuals with other medical conditions or taking treatments that could interfere with study evaluations
18 Years
65 Years
ALL
No
Sponsors
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Centre Hospitalier National d'Ophtalmologie des Quinze-Vingts
OTHER
Responsible Party
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Principal Investigators
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Isabelle Audo, Pr
Role: PRINCIPAL_INVESTIGATOR
CRMR Centre Hospitalier National D' Ophtalmologie Des Quinze-Vingts
Locations
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Centre Hospitalier National D' Ophtalmologie Des Quinze-Vingts
Paris, Île-de-France Region, France
Countries
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Central Contacts
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Facility Contacts
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Beata Monfort, PhD
Role: primary
Provided Documents
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Document Type: Study Protocol
Other Identifiers
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2025-A01308-41
Identifier Type: OTHER
Identifier Source: secondary_id
P25-02
Identifier Type: -
Identifier Source: org_study_id